Category: News

Regulatory Affairs Senior Associate – CMC – North America

Intrinsik Corp., is a North American consulting firm focusing on the regulatory challenges associated with the development of new products (pharmaceuticals, biologics, medical devices, consumer products, natural health products and cosmetics). We are continuing to grow, and will always welcome candidates with strong scientific skills, creativity and enthusiasm to join our team. Intrinsik has an …

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Lead Medical/Clinical Writer – North America

Intrinsik Corp., is a North American consulting firm that provides regulatory strategy and support from the pre- clinical stage through to market, including content authoring, preparation, submission and maintenance of regulatory documents in Canada, the United States, and Europe. Intrinsik has an immediate opening for a Lead Medical/Clinical Writer at our Mississauga, ON, Canada location …

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Senior Toxicologist – North America

Intrinsik Corp., is a North American consulting firm that is a recognized leader in toxicology and human health risk assessment, has an opening for the position of Senior Toxicologist within North America. We aim to offer our employees an environment that encourages professionalism, creativity, independence, and continual learning. The assets of any knowledge-based company are …

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Health Impact Assessment in Canada’s Impact Assessment Process

Introduction The new Canadian federal Impact Assessment Act requires that human health be assessed by employing the “best practices in Health Impact Assessment methods” for federally designated projects. As such, under the new Impact Assessment (IA) process, there is a greater focus on assessing the potential impacts on human health and well-being. The new requirements …

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New HHRA Guidance in BC

The British Columbia Ministry of Health recently issued its first version of the Guidance for Prospective Human Health Risk Assessment. The document is available for comment for one year, after which it will be updated to reflect current regulations and policy, and incorporate appropriate feedback. After that time, BC MOH notes that the guidance document …

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Nitrosamine Impurities – Clearing up the Obscurities

Nitrosamine Impurities – The Basics Nitrosamines (also referred to as N-nitrosamines) are compounds that contain a nitroso group bonded to an amine group. They are typically formed through a condensation reaction between an amine and nitrous acid. We have known about the existence of nitrosamine impurities for quite some time as they are commonly found …

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Study Monitoring During A Pandemic – What You Need To Know About Virtual And On-Site Monitoring Of Nonclinical Studies

COVID-19 has had an unmeasurable toll on us both personally and professionally.  It has affected every aspect of our lives, including the monitoring of nonclinical studies.  Arguably, monitoring has been impacted more than most other aspects of drug development.  While restrictions have loosened during the pandemic, working in tightly regulated environments such as nonclinical CROs …

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Radon

Radon is a radioactive gas that is found naturally in rocks, soil and water. Radon is formed by the natural breakdown of uranium in soil and rocks. Radon gas moves through the ground and can enter a home through cracks in floors, walls and the foundation. Radon levels will vary from one house to another, …

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Lead in Drinking Water

The level of public concern related to lead in drinking water is high, due to the reports of community exposures reported in the media in recent years. While the various governmental organizations in Canada and the US have lead-management strategies in place, the situation is complex. Why is lead present in drinking water? Lead is present …

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Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me?

Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me? What are PFAS? Perfluoroalkyl substances (PFAS) represent a group of man-made fluorinated organic compounds that are highly stable and persistent in the environment. These compounds have been used in industrial applications and consumer products since the 1950s, and many different PFAS have …

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